NCT02563197

Brief Summary

Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 23, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

September 18, 2015

Last Update Submit

April 25, 2017

Conditions

Bronchiectasis

Keywords

Device studyPeak inspiratory flow rateNon-cystic fibrosis bronchiectasisT-326 Inhaler

Outcome Measures

Primary Outcomes (1)

  • Peak inspiratory flow (L/min)

    Visit 2 (1-14 days after screening visit 1)

Secondary Outcomes (2)

  • Inspiratory volumes (V in L)

    Visit 2 (1-14 days after screening visit 1)

  • Inspiratory time (t in s)

    Visit 2 (1-14 days after screening visit 1)

Study Arms (1)

T-326

EXPERIMENTAL

Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow.

Device: T-326 Inhaler

Interventions

T-326 InhalerDEVICE

No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

T-326

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (HRCT) or magnetic resonance tomography (MRT)
  • Ability to reproducibly perform spirometry according to American Thoracic Society/European Respiratory Society criteria
  • Clinically stable in the opinion of the investigator at the time of the study visit.
  • Male and female patients ≥ 18 years of age.

You may not qualify if:

  • Pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in Forced expiratory volume in the first second (FEV1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks.
  • History of lung transplant.
  • Recent significant hemoptysis (≥ 300 mL or requiring blood transfusion) in the preceding six (6) weeks before screening.
  • Established diagnosis of bronchial asthma.
  • Established diagnosis of cystic fibrosis.
  • Proof of any relevant medical finding or disease in the last three (3) months which might interfere with participation in the study or patient safety (e.g. pneumothorax, uncontrolled hypertension, uncontrolled cardiac arrhythmia, myocardial infarction, cerebral vascular accident).
  • Relevant surgical history in the last 3 months (e.g., but not limited to abdominal, thoracic, ocular or brain surgery).
  • History or evidence of lung resection, thoracotomy, known aneurysm and severe scoliosis.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Gauting, Bavaria, 82131, Germany

Location

Unknown Facility

Landsberg am Lech, Bavaria, 86899, Germany

Location

Unknown Facility

München, Bavaria, 80336, Germany

Location

Unknown Facility

München, Bavaria, 80539, Germany

Location

Unknown Facility

München, Bavaria, 81241, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60389, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60596, Germany

Location

Unknown Facility

Neu-Isenburg, Hesse, 63263, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30625, Germany

Location

Unknown Facility

Großhansdorf, 22927, Germany

Location

Related Publications (1)

  • Stass H, Nagelschmitz J, Kappeler D, Sommerer K, Patzlaff A, Weimann B. Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis Bronchiectasis. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):156-163. doi: 10.1089/jamp.2018.1464. Epub 2019 Mar 8.

    PMID: 30848695DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 30, 2015

Study Start

November 23, 2015

Primary Completion

February 17, 2016

Study Completion

April 29, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

DE(10)